🇺🇸
United States · US · US:24658-999_8f808940-188e-4624-aee2-a84e3d7b58d7
Ursodiol
In shortageOrange BookUNIISPLATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPuraCap Laboratories, LLC
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124658999101000 CAPSULE in 1 BOTTLE (24658-999-10)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A075517
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ursodiol Capsule
Raw payload (JSON)
{
"unii": {
"unii": "724L30Y2QR",
"rxcui": "11065",
"inchikey": "RUDATBOHQWOJDD-UZVSRGJWSA-N",
"display_name": "URSODIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fb317988-a4e3-9c9a-e053-6294a90a5990": {
"match": "brand_token",
"title": "URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "4",
"published_date": "2026-06-01"
}
},
"productid": "24658-999_8f808940-188e-4624-aee2-a84e3d7b58d7",
"productndc": "24658-999",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075517",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Mar 14, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "URSODIOL",
"shortage_reason": "Ursodiol Capsule",
"shortage_status": "current",
"proprietary_name": "Ursodiol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075517",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "20210930",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code A05AA02.
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- GBCholurso 250mg tabletsMayoly UK Ltd
- IECholurso 500 mg film-coated tabletsLaboratoires Mayoly Spindler
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